Intra-uterine contraceptive appliance



June 21, 1966 J. SCHWARTZ ETAL 3,256,878

INTRA-UTERINE CONTRACEPTIVE APPLIANCE Filed May 28, 1964 m 2 N 7 mm 6 50 a V C f 1 E L K ON RA E R m JF. W-

2 FIG. 3 FIG. 6

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ATTORNEY 3 256,878 INTRA-UTERINE COlSlTRACEPTIVE APPLIANCE JeromeSchwartz, 1321 Club Drive, Hewlett Harbor,

N.Y., and Franklin C. Reyner, 29 Argyle Place, Rockville Centre, N.Y.

Filed May 28, 1964, Ser. No. 370,858 7 Claims. (Cl. 128-130) Thisinvention relates to an intra-uterine contraceptive appliance.

While such appliances are available in several different forms, theGrafenberg ring form has achieved the broadest professional acceptance.The appliance is positioned in the uterine cavity proximate to the entryto the oviducts. The ring is resilient and may be temporarily collapsedfor introduction through the cervical canal. While the invention isapplicable to multiring embodiments and other configurations, thepresent invention will be described with reference to severalmodifications of the classical Grafenberg ring.

Intra-uterine devices have one of the lowest failure rates of thepregnancy-prevention devices commonly in current use. The 1964McGraw-Hill Yearbook of Science and Technology reports a failure rate of1.7 per one hundred woman years of use for intra-uterine contraceptivedevices. One medical team reported that using the Grafenberg ring for atest involving 128 patients over a six-year period, which corresponds to648 exposure years, only six pregnancies resulted. However, in five ofthe reported pregnancies, the ring was found 'to have been expelled intothe cervical canal. Periodic checking of the device is thereforenecessary for effective use and to further reduce the failure rate. Thisneed for periodic checking is objectionable and restricts the use of thedevice. Such checking must be carried out by competent specialists inthe field.

The present invention seeks to overcome these and other difiicul-ties ofthe prior art in that it permits the user to verify for herself thepresence of the ring thus adding confidence and overcoming a seriouspsychological objection to the employment of this type of device.

The classical Grafenberg ring is currently made of stainless steel wirewound into a helix. The helix is then bent into a toroidal shape, about20 mm. in diameter, and retained in that form by means of a nylonfilament running through the center of the toroid and tied to the endsthereof.

The method and introduction of a Grafenberg ring is as follows:

The uterine cavity is sounded and note taken of the length and directionof the canal.. The cervical canal is then dilated with a Hegar dilator.With the ring straddling the fork of the introducer, the anterior lip ofthe cervix is grasped with a single tooth tenaculum and, with gentletraction, the ring is passed into the uterine cavity.

The literature reports that, as a rule, there will be some stainingfollowing the insertion of the ring probably due to abrasion of thecervical mucosa caused by the passage of the compressed ring through thecanal.

A feature of the present invention is that a nonabrasive ring isemployed thereby simplifying the introduction and avoiding the dangersand discomfort resulting from the insertion of the abrasive ring of theprior art.

Thus, one object of this invention is to provide an improvedintra-uterine contraceptive appliance.

Still another object of this invention is to provide a readily inserted,nonabrasive intra-uterine appliance.

Still a different object of this invention is to provide anintra-uterine appliance that does not act as an irritant to theendometirum.

- United States Patent A principal object of this invention is theprovision of an intra-uterine device whose presence may be verified bythe user.

A particular object of this invention is the provision of a siliconerubber intra-uterine contraceptive device.

These and other features, objects and advantages of the invention will,in part, be pointed outwith particularity and will, in part, becomeobvious from the following more detailed description of the invention,taken in conjunction with the accompanying drawing, which forms anintegral part thereof.

In the various figures of the drawing like reference charactersdesignate like parts.

In the drawing:

FIG. 1 shows a plan view of the apparatus of this invention;

FIG. 2 is a sectional side elevation taken along line 22 of FIG. 1;

FIG. 3 is a plan view of an alternative embodiment of this invention;

FIG. 4 is an enlarged transverse section taken along line 4-4 of FIG. 3;

' FIG. 5 is an enlarged transverse section taken along line 5-5 of FIG.3;

FIG. 6 is another alternative embodiment of the invention;

FIG. 7 is a plan view of still another alternative bodiment of theinvention;

' FIG. 8 is an enlarged transverse section taken along line 8-8 of FIG.7;

FIG. 9 is a fragmentary vertical body section showing the apparatusproperly positioned; and

FIG. 10 is a schematic fragmentary section along line 10-40 of FIG. 9.

Referring now to the drawing, in FIG. 1 there is shown a stainless steelring 12. This ring is formed by winding stainless steel wire ofapproximately 0.5 mm. in diameter into a helix approximately3 mm. indiameter, and then forming the helix into a toroid having an outsidediameter of approximately 20 mm. One end of the helix is tapered to fitinto the other end of the helix. A resilient ring is used because of thenecessity of contracting the device in order to permit its insertionthrough the narrow cervical canal.

To avoid scraping and irritation of the canal during insertion and toavoid irritation of the uterus, the wire is covered by a resilient layer14 of a synthetic resin. Physiologically inert silicone rubber such asGeneral Electric SE-450 silicone rubber is suitable. Otherphysiologically inert materials may be employed. Nonplasticized vinylacetate and ethylene copolymers are presently regarded as suitable forthis application.

The coating 14 is molded over the ring in a conventional cavity mold toform the intra-uterine portion 16 of the device. During this moldingoperation, a tail portion 18, approximately mm. long and 2.5 mm. indiameter is also formed. The length of the stem portion may be variedover the range 4 cm. to 8 cm. to accommodate individual requirements.The tail is provided with one or more nodules 20. 7

FIGS. 9 and 10 show the intra-uterine portion 16 positioned in theuterus U with the tail 18 extending through the uterine canal C and thenodules 20 exposed in the vaginal vault V. Thus the user can digitallypalpate the nodules to verify the presence and location of the device.

Silicone rubber is the presently preferred material because it is soft,physiologically inert, and resilient. Neither the user nor her partnerduring intercourse can detect the presence of the device.

A rare possibility exists of a cervical canal pregnancy. The presence ofthe tail member tends to prevent this type of pregnancy.

In FIGS. 3, 4 and 5, there is shown an alternative embodiment 22 whereina nylon monofilament 24, of 0.5 mm. O.D. is embedded in the tail portion26. The nylon is threaded through the coil 28, knotted to form a loopthereby tying the coil into a toroid, and then passed down to thelocation of nodules 30 where knots are formed to facilitate theformation of a strong mechanical bond with the silicone rubber coating32. The use of the nylon filament as a reinforcement permits the use ofa thinner silicone rubber tail portion 26 where desired.

In the device 34- shown in FIG. 6, the rubber coating over the nylonthread 36 has been eliminated permitting employment of the device inwomen who may be extremely sensitive to the presence of the tail portion18 of FIG. 1. As in the previous embodiments, helically wound springwire is formed into a toroid 38, the ends of which are tied together.Toroid 38 is then covered. by silicone rubber. layer 40. Knots may alsobe provided in the filament 36 to aid in anchoring the rubber layer 40thereto.

Still a different arrangement is shown in FIGS. 7 and 8 where thehelically wound, toroidal spring has been eliminated. The device of thisembodiment is comprised of a toroidal ring portion 44 having a flexiblestiffening web 46. Tail 48 is comolded therewith and is provided withnodules 50. It will be understood that the spring may be incorporated,if desired, in combination With the web.

The silicone rubber toroid may still be collapsed to permit insertion ofthe device.

While silicone rubber is presently preferred, other suitable materialsare likely to become available in the future as the result of changes intechnology. The material should be autoclavable to permit sterilization.The material should also be soft, resilient, have high tensile strengthand be physiologically inert.

As has been disclosed earlier, instances are known of the expulsion ofthe device without the user becoming aware of the incident. With thedevice of this invention, the user may digitally palpate the nodule onthe flexible stem. The absence of the nodules signifies that the devicehas been expelled. If the nodules are found too far below the cervix,then the user is immediately alerted that the device is improperlypositioned. Thus the capability of self-testing is a significantadvance.

There has been disclosed heretofore the best embodiments of theinvention presently contemplated and it is to be understood that vaniouschanges and modifications may be made by those skilled in the artwithout departing from the spirit of the invention.

4 What is claimed is: 1. An intra-uterine contraceptive devicecomprising: (a) a toroidal member composed of:

(l) a resilient self-erecting supporting ring adapted to be placed undertension and thereby fold in order to fit through a normal cervicalcanal, said ring reverting to its initial shape when the tensile forcesare released;

(2) a soft silicone rubber covering encasing said ring; and

(b) a flexible stem having a fixed end joined to said toroidal memberand a free end, said stem having a length such that when said toroidalmember is positioned in the uterus, said stem is adapted to lie in thecervical canal with the free end extending into the vagina.

2. The device of claim 1 wherein said self-erecting ring is a toroidalhelically coiled spring.

3. The device of claim 1 wherein said stem is a nylon filament.

4. The device of claim 1 wherein said stem is formed of silicone rubber.

5. The device of claim 4 wherein said stem has embedded therein arelatively inelastic fiber.

6. The device of claim 1 including at least one nodule of greaterdimension than said stem affixed to the free end of said stem.

7. An intra-uterine contraceptive device comprising:

(a) a toroidal member composed of:

(l) a resilient self-erecting supporting ring adapted to be placed undertension and thereby fold in order to fit through a normal cervicalcanal, said ring reverting to its initial shape when the tensile forcesare released;

(2) a soft, physiologically inert synthetic resin covering encasing saidring; and

(b) a flexible stem having a fixed end joined to said toroidal memberand a free end, said stem having a length such that when said toroidalmember is positioned in the uterus, said stem is adapted to lie in thecervical canal with the free end extending into the vagina.

References Cited by the Examiner UNITED STATES PATENTS 3,200,815 8/1965Margulies 128-130 ADELE M. EAGER, Primary Examiner.

1. AN INTRA-UTERINE CONTRACEPTIVE DEVICE COMPRISING: (A) A TOROIDALMEMBER COMPOSED OF: (1) A RESILIENT SELF-ERECTING SUPPORTING RINGADAPTED TO BE PLACED UNDER TENSION AND THEREBY FOLD IN ORDER TO FITTHROUGH A NORMAL CERVICAL CANAL, SAID RING REVERTING TO ITS INITIALSHAPE WHEN THE TENSILE FORCES ARE RELEASED; (2) A SOFT SILICONE RUBBERCOVERING ENCASING SAID RING; AND (B) A FLEXIBLE STEM HAVING A FIXED INDJOINED TO SAID TOROIDAL MEMBER AND A FREE END, SAID STEM HAVING A LENGTHSUCH THAT WHEN SAID TOROIDAL MEMBER IS POSITIONED IN THE UTERUS, SAIDSTEM IS ADAPTED TO LIE IN THE CERVICAL CANAL WITH THE FREE END EXTENDINGINTO THE VAGINA,